Lung Cancer (NSCLC)Phase 2NCT07874464
Prospective Phase II Study of Concurrent Radiotherapy Combined With Full-Course Immunotherapy or Consolidation Immunotherapy for Locally Advanced NSCLC
A Phase 2 study testing Induction chemoimmunotherapy, radiotherapy and Concurrent Chemotherapy in people with Lung Cancer (NSCLC), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in patients with unresectable, locally advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Induction chemoimmunotherapy, radiotherapy and Concurrent Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2026to 12 Oct 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-75 years ;
- Histologically or cytologically confirmed, locally advanced, unresectable stage III non-small cell lung cancer (NSCLC);
- Wild-type EGFR, ALK, and ROS1;
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
- Availability of unstained archival tumor tissue samples sufficient for analysis;
- Life expectancy of ≥12 weeks;
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- World Health Organization (WHO) performance status of 0 or 1;
- Female patients must not be breastfeeding;
- Adequate organ and bone marrow function, meeting all of the following criteria: Forced expiratory volume in 1 second (FEV1) ≥800 mL; Absolute neutrophil count ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥9.0 g/dL; Creatinine clearance ≥50 mL/min, calculated using the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin ≤1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN.
Who cannot join
- Patients meeting any of the following criteria will not receive induction therapy:
- Concurrent participation in another clinical study, unless it is an observational, non-interventional study;
- Mixed small cell and non-small cell lung cancer histology;
- Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody;
- Major surgery within 4 weeks before study entry, excluding procedures for vascular access;
- Active autoimmune disease or a history of autoimmune disease within the past 2 years;
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- Active inflammatory bowel disease or a history of inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
- History of primary immunodeficiency;
- History of organ transplantation requiring immunosuppressive therapy;
- Uncontrolled intercurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, cardiac arrhythmia, active peptic ulcer disease or gastritis, or active bleeding disorders; known hepatitis B surface antigen (HBsAg) positivity with HBV DNA >500 IU/mL, hepatitis C, or human immunodeficiency virus (HIV) infection; or psychiatric illness or social circumstances that would limit compliance with study requirements or impair the ability to provide written informed consent;
- Known history of tuberculosis, except for old, inactive pulmonary tuberculosis;
- History of another primary malignancy within the past 5 years, except adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
- Pregnancy or breastfeeding; or male or female patients of reproductive potential who are not using effective contraception.
- Exclusion Criteria for Concurrent Chemoradiotherapy After Induction Therapy:
- Patients meeting any of the following criteria will not proceed to concurrent chemoradiotherapy:
- Development of distant metastases;
- Locoregional disease progression that, in the judgment of the radiation oncologist, precludes definitive chemoradiotherapy because normal tissue dose constraints cannot be met;
- WHO performance status of 2-4;
- Any of the following organ or bone marrow impairments: FEV1 <800 mL; Absolute neutrophil count <1.5 × 10⁹/L; Platelet count <100 × 10⁹/L; Hemoglobin <9.0 g/dL; Creatinine clearance <50 mL/min, calculated using the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin >1.5 times ULN; AST and ALT >2.5 times ULN.
- Exclusion Criteria for Consolidation Immunotherapy After Concurrent Chemoradiotherapy:
- Patients meeting any of the following criteria will not proceed to consolidation immunotherapy:
- Disease progression during concurrent chemoradiotherapy;
- Use of immunosuppressive medication within 28 days before the first dose of dual immunotherapy, except for intranasal or inhaled corticosteroids at physiological doses, or systemic corticosteroids at doses not exceeding 10 mg/day of prednisone or equivalent. Corticosteroids used to manage chemoradiotherapy-related toxicity are permitted;
- Unresolved toxicity of CTCAE grade >2 from prior chemoradiotherapy;
- Grade ≥2 pneumonitis resulting from prior chemoradiotherapy;
- Any previous grade ≥3 immune-related adverse event (irAE), or any unresolved irAE of grade >1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Bo Qiu, +86-020-87343031, qiubo@sysucc.org.cn
About this study
Official title: A Prospective Phase II Study to Evaluate Concurrent Radiotherapy Combined With Full-course Immunotherapy or Concurrent Radiotherapy Combined With Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer
This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in patients with unresectable, locally advanced non-small cell lung cancer.
Read the detailed description
This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in unresectable, locally advanced non-small cell lung cancer. Patients are randomized in a 1:1 ratio to experimental group and control group. The experimental group will receive induction chemoimmunotherapy, concurrent chemoradiotherapy, and full-course immunotherapy during the chemoradiotherapy phase and consolidation phase. Patients in the control group will receive concurrent chemoradiotherapy and consolidative immunotherapy.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Induction chemoimmunotherapy, radiotherapy, Concurrent Chemotherapy, consolidation immunotherapy, full-course immunotherapy
- Keywords
- Unresectable Locally Advanced Non-Small Cell Lung Cancer, Induction Chemoimmunotherapy, Hypofractionated Concurrent Chemoradiotherapy, Tislelizumab
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction chemoimmunotherapyDrug
Nab-paclitaxel 260 mg/m² + cisplatin 75 mg/m² + tislelizumab 200 mg on day 1, Q3W，3 cycles.
radiotherapyRadiation
Thoracic radiotherapy at a definitive dose using intensity-modulated radiation therapy or Volumetric Modulated Arc Therapy.
Concurrent ChemotherapyDrug
Nab-paclitaxel 50 mg/m² + cisplatin 25 mg/m² on day 1, weekly.
consolidation immunotherapyDrug
Tislelizumab 200 mg on day 1, every 3 weeks.
full-course immunotherapyDrug
Immunotherapy (Tislelizumab 200 mg d1) will be administered during the concurrent chemoradiotherapy phase and consolidation phase, but not on radiotherapy days.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Experimental | Patients are planned to receive induction chemoimmunotherapy, concurrent chemoradiotherapy, and full-course immunotherapy during concurrent chemoradiotherapy phase and consolidation phase. Receives: Drug: Induction chemoimmunotherapy; Radiation: radiotherapy; Drug: Concurrent Chemotherapy; Drug: consolidation immunotherapy; Drug: full-course immunotherapy |
| The control group | Active comparator | Patients are planned to receive concurrent chemoradiotherapy and then consolidation immunotherapy. Receives: Radiation: radiotherapy; Drug: Concurrent Chemotherapy; Drug: consolidation immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival rate
From the first day of treatment to the day of progression or the day of death.
Measured: 18 months
Secondary outcomes (3)
Overall survival
It was calculated from the first day of treatment to the day of death.
Measured: 18 months
Objective response rate
The proportion of patients evaluated as CR or PR
Measured: 1 year
Incidence of Treatment-related Adverse Events
Adverse effects are graded according to the CTCAE 5.0 version.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion12 Oct 2028 (estimated)
- Study completion12 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
- Investigators
- Hui Liu, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874464
- Sponsor's protocol ID
- GAST0-10142
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24.
PubMed 32979984Yang X, Yin R, Xu L. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 Aug 30;379(9):e14. doi: 10.1056/NEJMc1808251. No abstract available.
PubMed 30179394Cheng W, Kang K, Zhao A, Wu Y. Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer. J Hematol Oncol. 2024 Jul 27;17(1):54. doi: 10.1186/s13045-024-01581-2.
PubMed 39068460Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
PubMed 28885881Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.
PubMed 25601342Machtay M, Bae K, Movsas B, Paulus R, Gore EM, Komaki R, Albain K, Sause WT, Curran WJ. Higher biologically effective dose of radiotherapy is associated with improved outcomes for locally advanced non-small cell lung carcinoma treated with chemoradiation: an analysis of the Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):425-34. doi: 10.1016/j.ijrobp.2010.09.004. Epub 2010 Oct 25.
PubMed 20980108Bi N, Wang L. Superiority of concomitant chemoradiation over sequential chemoradiation in inoperable, locally advanced non-small cell lung cancer: challenges in the selection of appropriate chemotherapy. Semin Radiat Oncol. 2015 Apr;25(2):122-32. doi: 10.1016/j.semradonc.2014.11.003. Epub 2014 Nov 18.
PubMed 25771417Bezjak A, Temin S, Franklin G, Giaccone G, Govindan R, Johnson ML, Rimner A, Schneider BJ, Strawn J, Azzoli CG. Definitive and Adjuvant Radiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Society for Radiation Oncology Evidence-Based Clinical Practice Guideline. J Clin Oncol. 2015 Jun 20;33(18):2100-5. doi: 10.1200/JCO.2014.59.2360. Epub 2015 May 5.
PubMed 25944914